Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
Arthrodesis of the foot, wrist and elbow.
Small and long bone osteotomies.
Fracture fixation of small bones, small bone fragments and long bones.

Device Description

The 3.0mm Biomet Cannulated Screw System consists of bone screws of various lengths and are Ti alloy partially threaded screws with the associated 3.0mm washer. They are offered in both a sterile and non-sterile configuration. The 3.0mm Biomet Cannulated Screw System also contains dimensionally optimized corresponding instruments which are used with the 3.0mm Biomet Cannulated Screws and washers to aid in the alignment and stabilization of fractures to the skeletal system.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "3.0mm Biomet Cannulated Screw System." It seeks to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to prove specific performance criteria against predefined thresholds.

Therefore, the requested information elements related to acceptance criteria and a study proving those criteria are not directly applicable or available in this specific type of regulatory submission document. This document focuses on demonstrating that the new device is as safe and effective as a previously cleared device.

However, I can extract the relevant information from the document as it pertains to the basis for substantial equivalence, which includes some performance data.

Here's a breakdown based on your request, as much as can be derived from the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not specify formal "acceptance criteria" for clinical performance that would typically be seen in a clinical trial. Instead, the performance is compared against predicate devices to demonstrate substantial equivalence. The non-clinical tests indicate that the new device's performance is "equal to or better than the predicate devices."

Acceptance Criteria Category	Acceptance Criteria (Implicit from Equivalence)	Reported Device Performance
Torsional Strength	Comparable to or better than predicate devices (e.g., FRS screw K062352, DartFire screw K082320).	Equal to or better torsional yield strength than predicate screws.
Axial Pullout Strength	Comparable to or better than predicate devices.	Equal to or better than predicate devices.
Insertion/Removal Torque	Comparable to or better than predicate devices.	Equal to or better than predicate devices.
Material	Same material (Ti-6Al-4V alloy per ASTM F136) as K140891, and similar to K082874 and K962823 predicate devices.	Identical to K140891, similar to K082874 and K962823.
Design Features	Similar in design and dimension to K140891 (line extension), and similar to K082874 and K962823 predicate devices.	Similar to K140891, K082874, and K962823.
Sterilization	Identical to K140891, and similar to K082874 and K962823 predicate devices.	Identical to K140891, similar to K082874 and K962823.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The non-clinical tests were conducted per ASTM F543, which specifies testing methodologies, but the sample size used for these specific tests is not provided in this summary.
Data Provenance: Not specified, but generally, bench testing (non-clinical) occurs in a lab setting, not tied to patient data. Since no clinical studies were performed, there is no patient data provenance to report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device underwent non-clinical (bench) testing, not clinical studies requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This was bench testing, not a clinical study involving human judgment or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a bone fixation screw system, not an AI/imaging device. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (bone screw), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" or reference for performance was established by standardized mechanical testing methodologies (ASTM F543) and comparison to the performance of legally marketed predicate devices. There is no clinical ground truth (like pathology or outcomes data) mentioned because no clinical studies were performed.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is not a machine learning algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Biomet Manufacturing Corporation Ms. Suzana Otaño Regulatory Affair Manager 56 East Bell Drive PO Box 587 Warsaw, Indiana 46581

December 30, 2014

Re: K143188

Trade/Device Name: 3.0mm Biomet Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 3, 2014 Received: November 5, 2014

Dear Ms. Otaño:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Suzana Otaño

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K143188

Device Name

3.0mm Biomet Cannulated Screw System

Indications for Use (Describe)

1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
1. Arthrodesis of the foot, wrist and elbow.
1. Small and long bone osteotomies.

Fracture fixation of small bones, small bone fragments and long bones.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the 3.0mm Biomet Cannulated Screw System 510(k) premarket notification.

Sponsor:	Biomet Manufacturing Corp.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact:	Suzana OtañoRegulatory Affairs Manager, TraumaPhone: 305-269-6386
Date:	December 19, 2014
Subject Device:	Trade Name: 3.0mm Biomet Cannulated Screw SystemCommon Name: Screw, Fixation, BoneClassification Name:• HWC- Smooth or Threaded Metallic Bone Fixation Fastener (21 CFR 888.3040)

Legally marketed devices to which substantial equivalence is claimed:

Biomet Cannulated Screw System - K140891
BioDrive Cannulated Screw System - K082874
Synthes Sterile 3.0 mm Cannulated Screw and Threaded Washer - K962823
FRS Screw K062352 ●
Wright Compression Screws (DartFire) – K082320

Device Description

Intended Use and Indications for Use

1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
1. Arthrodesis of the foot, wrist and elbow.
1. Small and long bone osteotomies.
1. Fracture fixation of small bones, small bone fragments and long bones.

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Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following technological characteristics:

Materials: The Biomet Cannulated Screw System screws and washers are fabricated from Ti-6Al-4V alloy per ASTM F136. The materials used in the 3.0mm Biomet Cannulated Screw System are identical to those used in K140891, and similar to those used in K082874, and K962823.
Design Features: The 3.0mm Biomet Cannulated Screws are similar in design and dimension to the Biomet Cannulated Screw System cleared via K140891 and are considered a line extension. The design of the subject device is similar to those cleared in K082874 and K962823.
. Sterilization: The sterilization configurations of the 3.0mm Biomet Cannulated Screw System is identical to that of the Biomet Cannulated Screw System cleared via K140891. The sterilization configurations are similar to that of the devices cleared via K082874 and K962823.

Summary of Performance Data (Nonclinical and/or Clinical)

. Non-Clinical Tests
- Non-clinical performance testing included torsional, axial pullout and o insertion/removal torque mechanical tests per ASTM F543. The axial pullout and insertion/removal torque values were equal to or better than the predicate devices. Engineering analysis of the torsional yield strengths demonstrated that the 3.0mm Biomet Cannulated Screws have equal to or better torsional yield strength than the predicate screws including the FRS screw (K062352) and the DartFire screw (K082320). Results of bench testing in conjunction with engineering analysis indicate that the subject screws are substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
Clinical Tests
- None provided as a basis for substantial equivalence. o

Substantial Equivalence Conclusion

The 3.0mm Biomet Cannulated Screw System is substantially equivalent to the commercially available Biomet Cannulated Screw System cleared via K140891, as well as the devices cleared via K082874, K082320, K062352 and K962823.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.